In Vitro Bioequivalence Studies

In Vitro Bioequivalence Studies
Product Description

PolyCrystalLine offers a wide range of Pre-formulation studies which includes In vitro bioequivalence studies. It is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the fundamental bioequivalence assumption that when two drug products are equivalent in bioavailability, they will reach the same therapeutic effect. Contact us for more information.

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PolyCrystalLine S.p.A

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Experienced Technicians; Quality Service
  • Supplied from
    Italy
More specifications Fewer specifications
Sales Markets
Show more Show less

PolyCrystalLine S.p.A

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
View company profile

More Products from PolyCrystalLine S.p.A (17)

  • Process Development

    Product Process Development

    We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up allowing for batches of grams to kilograms of small-scale production, while ensuring flexible and robust procedure that can easily be transferred to pilot-scale, and finally to high volume ind...
  • Api-Excipient Compatibility Studies

    Product Api-Excipient Compatibility Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes API-excipient compatibility studies. It contains excipients which can affect the chemical, physical and therapeutical properties, product stability and may even cause a change in the API polymorphic form. Its interactions is a cr...
  • Cgmp Quality Control

    Product Cgmp Quality Control

    PolyCrystalLine offers a wide range of analytical services which includes cgmp quality control. Its provide a full complement of state-of-the-art gmp analytical testing resources and expertise to support cgmp quality control testing for raw materials, active pharmaceutical ingredients (api) and intermediat...
  • Co-Crystals Screening

    Product Co-Crystals Screening

    PolyCrystalLine offers a wide range of solid form screening which includes co-crystals screening. It is an molecular crystals in which at least one of the compounds is an active pharmaceutical ingredient (api). Salts are considered different from co-crystals provided that its crystals formed by ionic multi...
  • custom synthesis

    Product custom synthesis

    Api and impurities
  • Dissolution Testing

    Product Dissolution Testing

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes Dissolution testing. It is a Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilisation of the drug under physiological...
  • Kilo-Lab

    Product Kilo-Lab

    Kilo Lab, available for HPAPI, narcotic or controlled substances, pressure reactions
  • Method Development & Validation

    Product Method Development & Validation

    PolyCrystalLine offers a wide range of analytical services which includes method development & validation. It can be entrusted with the most sensitive projects for method development and validation of api’s intermediates, raw materials and finished products. Contact us for more information.
  • Physical Characterization

    Product Physical Characterization

    PolyCrystalLine offers a wide range of analytical services which includes physical characterization. Its an physicochemical properties of a compound is essential so that the formulation process can be rational and streamlined. Contact us for more information.
  • Polymorph Screening

    Product Polymorph Screening

    PolyCrystalLine offers a wide range of solid form screening which includes polymorph screening. In an early stage of drug development helps to avoid manufacturing problems, to fine-tune the performance of drugs and provides space for innovations. Contact us for more information.
  • Route scouting

    Product Route scouting

    API route scouting, up to kilo-Lab
  • Salts Screening

    Product Salts Screening

    PolyCrystalLine offers a wide range of solid form screening which includes salts screening. It is one of the primary solid-state approaches used to modify the physical properties of apis, a major limitation within this approach is that the api must possess a suitable (basic or acidic) ionisable site. Conta...
show all 17 other products

PolyCrystalLine S.p.A resources (1)